Vertebral Artery and Cerebral Hemodynamics After Various Head Positions & Manipulation in Patients With Neck Pain

Stroke Clinical Trial

Official title:

Changes in Vertebral Artery and Cerebral Hemodynamics Following Various Head Positions & Cervical Manipulation in Patients With Chronic/Recurrent Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667821
• Other study ID #: 162001
• Status: Completed
• Phase: N/A
• First received: January 18, 2016
• Last updated: September 11, 2017
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Investigators are performing a study to determine, in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements, including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow dynamics affecting brain perfusion, and extend the current data set on these variables

Description:

The goal of the study is to further investigate in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine positions, including manipulation, in vivo under clinically relevant circumstances using two advanced MRI technology on the vertebral and posterior cerebral and cerebellar blood flow dynamics affecting brain perfusion. According to the knowledge of the investigators, a study utilizing MRI to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these blood vessels has yet to be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults aged 18 years and older with chronic/recurrent neck pain Grade II.

2. Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.

Exclusion Criteria:

1. A history of neck pain with associated arm pain within the last 6 months

2. Any current or history of neurologic symptoms including facial or extremity weakness, abnormal sensation to the face, body, or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing

3. History of new or severe (Visual Analogue Scale >6) headaches in the last 3 months

4. Any contraindications to MRI

5. Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Cerebrovascular Accident
• Neck Pain
• Stroke
• Vertebral Artery Dissection

Intervention

Other:
• Head positions and spinal manipulation
Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.

Locations

Country	Name	City	State
Canada	St. Joseph Healthcare, Research Imaging Institute	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	National Chiropractic Mutual Insurance Company (NCMIC)

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Bendick PJ, Jackson VP. Evaluation of the vertebral arteries with duplex sonography. J Vasc Surg. 1986 Mar;3(3):523-30. — View Citation

Boyle E, Côté P, Grier AR, Cassidy JD. Examining vertebrobasilar artery stroke in two Canadian provinces. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S194-200. doi: 10.1016/j.jmpt.2008.11.019. — View Citation

Cagnie B, Jacobs F, Barbaix E, Vinck E, Dierckx R, Cambier D. Changes in cerebellar blood flow after manipulation of the cervical spine using Technetium 99m-ethyl cysteinate dimer. J Manipulative Physiol Ther. 2005 Feb;28(2):103-7. — View Citation

Cassidy JD, Boyle E, Côté P, He Y, Hogg-Johnson S, Silver FL, Bondy SJ. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S201-8. doi: 10.1016/j.jmpt.2008.11.020. — View Citation

Haynes MJ. Doppler studies comparing the effects of cervical rotation and lateral flexion on vertebral artery blood flow. J Manipulative Physiol Ther. 1996 Jul-Aug;19(6):378-84. — View Citation

Johnson C, Grant R, Dansie B, Taylor J, Spyropolous P. Measurement of blood flow in the vertebral artery using colour duplex Doppler ultrasound: establishment of the reliability of selected parameters. Man Ther. 2000 Feb;5(1):21-9. — View Citation

Licht PB, Christensen HW, Højgaard P, Høilund-Carlsen PF. Triplex ultrasound of vertebral artery flow during cervical rotation. J Manipulative Physiol Ther. 1998 Jan;21(1):27-31. — View Citation

Licht PB, Christensen HW, Svendensen P, Høilund-Carlsen PF. Vertebral artery flow and cervical manipulation: an experimental study. J Manipulative Physiol Ther. 1999 Sep;22(7):431-5. — View Citation

Mitchell JA. Changes in vertebral artery blood flow following normal rotation of the cervical spine. J Manipulative Physiol Ther. 2003 Jul-Aug;26(6):347-51. — View Citation

Rubinstein SM, Peerdeman SM, van Tulder MW, Riphagen I, Haldeman S. A systematic review of the risk factors for cervical artery dissection. Stroke. 2005 Jul;36(7):1575-80. Epub 2005 Jun 2. Review. — View Citation

Sakaguchi M, Kitagawa K, Hougaku H, Hashimoto H, Nagai Y, Yamagami H, Ohtsuki T, Oku N, Hashikawa K, Matsushita K, Matsumoto M, Hori M. Mechanical compression of the extracranial vertebral artery during neck rotation. Neurology. 2003 Sep 23;61(6):845-7. — View Citation

Zaina C, Grant R, Johnson C, Dansie B, Taylor J, Spyropolous P. The effect of cervical rotation on blood flow in the contralateral vertebral artery. Man Ther. 2003 May;8(2):103-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Blood Flow Through Vertebral Artery	Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood flow (mL/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05	The series of fMRI sequences will be performed on each participant immediately after each procedure.
Primary	Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation	Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05	The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.
Secondary	Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.	ASL allows one to separate the blood flow from the BOLD effect, thus giving clear measures of perfusion. More specifically ASL will be used to measure blood perfusion and allow extraction of metabolic difference from flow differences in BOLD imaging. It is a quantitative technique, yielding values with units of ml/(100g of tissue)·min-1.	The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.